Helix Elite" Inactivated Standard: Inactivated recall
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number…
Why was Helix Elite" Inactivated Standard: Inactivated recalled?
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10845357043563; Lot Number: HE0065-29
- Product
- Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number…
- Recalling firm
- Microbiologics Inc
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the states of TX. UK.
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)